View Article PDF

The Ministry of Health (MOH) recently released a consultation document outlining proposals for the New Zealand Medicinal Cannabis Scheme (NZMCS) and completed a series of public consultations seeking feedback from industry, patients and medical professionals on a number of complex regulatory issues.1 With less than three months left to finalise the new scheme, pressure is mounting to balance the sometimes conflicting expectations of the various stakeholders. Medical professionals overseas and in New Zealand have long expressed concerns about the quality of evidence concerning the medical benefits of cannabis (ie, specifically the limited number of double-blind placebo-controlled trials).2,3 As a consequence, engaging medical professionals in similar regimes overseas has proved a key challenge.4

Broadly, the MOH consultation document proposes a pharmaceutical access model where products will be available via prescription from pharmacies. The discussion document asked whether an additional recommendation from a specialist doctor should also be required. This level of oversight would be higher than for most other medicines, including opioids—an irony that has not escaped some commentators.5 The suggestion that the New Zealand scheme will require specialist sign-off has attracted negative feedback from patients and the industry, and a mixed response from medical professionals concerned there will not be enough specialists and with the additional pressure placed on the resources of the health system.6

In Australia, the requirement for specialist sign-off led to the opening of private ‘cannabis clinics’ with specialist teams on site, adding to the cost of such consultations and related inequities. However, recent modifications of the Australian regime have addressed these issues, with monthly prescribing figures subsequently increasing 10-fold, from 229 in August 2018 to 2,206 in July 2019.7 The modifications include the streamlining of the GP application process using an online portal, thus avoiding the paperwork previously involved, and most states now allowing specialist GPs to prescribe without having to be endorsed by condition specialists (eg, pain specialists).8

Further key issues put forward for discussion include what medical cannabis products will be available and the related manufacture standards. Smoking and edible products have already been ruled out due to the health risks of smoking and variability in metabolism of edibles respectively, but vaping will most likely be permitted. In terms of manufacture, the Ministry has suggested one scenario in which all products will need to comply with Good Manufacturing Practice (GMP) requirements, the gold standard for pharmaceutical products. An alternative approach is to allow some products to be manufactured to a lower Good Production Practice (GPP) standard. The proposed GPP standard is based on the Canadian approach to non-prescription health products containing cannabis. These products do not undergo any pre-market review for safety.1 Given this NZMCS proposal is strongly based in the pharmaceutical paradigm, it is unclear whether GPs would be comfortable prescribing products manufactured to any standard lower than GMP. Many countries have already adopted GMP for medicinal cannabis and some fledgling New Zealand medicinal companies have expressed interest in this international export market.

We are left wondering if the GPP standard has been proposed in anticipation of a more liberal approach to cannabinoids in the future. The New Zealand Medical Cannabis Council, the cannabis industry group, is currently lobbying to reschedule cannabis-derived cannabidiol (CBD) products from ‘prescription’ to ‘pharmacy-only’ medicines. We have previously argued that CBD products could be classified as dietary supplements due to the absence of the psychoactive ingredient THC.9 CBD is marketed in this way in some countries, but legal uncertainties remain.10 For example, French authorities recently released a new interpretation of the law that allows traces of THC (0.2%) to be present in the plant, but not in the finished CBD products, leading to the closure of numerous ‘CBD cafes’.11 Meanwhile, an American CBD producer received a license to sell CBD foods and supplements in Bulgaria, the first European Union country to officially regulate CBD as a food (potentially at odds with EU law requiring prior market authorisation by the European Food Safety Authority).12 The current review of CBD by the US Food and Drug Administration will likely influence the global industry and regulations in other countries,13 including New Zealand.

The speed at which the NZMCS is now being finalised raises concerns that the new framework may have deficiencies and unintended impacts. While the Misuse of Drugs (Medicinal Cannabis) Amendment Bill was introduced into the house in late January 2018 (as part of the Government’s 100 day plan), it took 11 more months to pass into law, and the legislation states the regulations must be finalised by 18 December 2019. This leaves an extremely tight timeframe to resolve some complex issues. As previously seen with the attempt to regulate “legal highs” via the Psychoactive Substances Act, a rushed policy process can have fatal consequences for implementation.14–16

On social media, medicinal cannabis patients have expressed their frustration at the MOH scheduling of July NZMCS consultation sessions for patients in the evening when their symptoms worsen, and this appears to have contributed to low turnouts.17 In contrast, the morning consultation sessions for the industry were very well attended. This raises the question of who will be the central focus of the regime. The composition of the Medicinal Cannabis Advisory Group includes two representatives from the industry: a cannabis growing company and a private consultancy specialising in commercialisation of biomedical and pharmaceutical products. Some commentators have argued that keeping the industry at arm’s length during the development phase would have been preferable.18 The decision to recover the cost of the new regime from industry licensing fees also appears to establish a dangerous dependency on the commercial success of the new sector. Proposed high licensing fees also create barriers for small-scale, artisan producers who are less focused on commercial success.

The nascent domestic New Zealand medicinal cannabis industry may face considerable competition from already well-established firms from the US, Canada and Israel, raising questions about the extent to which the Government is interested in nurturing a domestic industry. In Thailand, which legalised medicinal cannabis earlier in 2019, foreign investment and imports will be prohibited for five years to allow the domestic medical cannabis industry to become established.19 Under the Jamaican medicinal cannabis scheme (established in 2015), licensed companies must have ‘substantial’ Jamaican ownership control.20 A domestic medicinal cannabis sector may provide opportunities for enhanced regulatory control and local economic development and employment.

There are also questions about the equity of the new regime with regard to addressing the previous disproportionately high Māori arrest rate for minor cannabis offences and the need to promote Māori economic development. The New Zealand Health Survey found that 10.2% of Māori compared to 4.4% of Pakeha self-reported using cannabis medicinally.21,22 The recent legalisation of cannabis in Illinois included expungement of previous cannabis convictions (involving around 770,000 cannabis-related records), and support for people from communities that had been disproportionately impacted by cannabis law enforcement to obtain cannabis business licenses. The Jamaican government is currently implementing an Alternative Development Programme to support local farmers to grow cannabis in a regulated medicinal scheme environment.23

Finally, throughout the NZMCS consultation process there has been little mention of how the medicinal scheme will fit with a possible framework for recreational cannabis use if next year’s referendum is positive. With “grow your own” as an option under the recently released Government framework,24 patients may opt to utilise this means of supply as an alternative to a strictly regulated and likely more expensive NZMCS. Alternatively, if the referendum does not endorse legal recreational cannabis access, disaffected patients may continue to access the potentially cheaper cannabis black market. In Canada, following legalisation of recreational use, the Canadian Medical Association has called for abandonment of medical access scheme, stating it is “no longer necessary”.25 The danger with this outcome is those wishing to use cannabis for medicinal reasons may not have access to safer, medical grade cannabis products and may be less likely to seek professional medical advice.26

Experience from overseas shows medicinal cannabis schemes can be too strictly regulated with overly bureaucratic systems leading to higher healthcare costs, barriers to access and overburdening of the health system. Yet if cannabis is to be treated as a medicine, patient safety and treatment efficacy must remain central principles. There are clear reasons to keep the medicinal cannabis industry at arm’s length from regulatory design decisions. Experience from overseas also suggests that schemes often need to be adjusted over the years to achieve their original objectives, and this underlines the need for regulatory design flexibility and, importantly, ongoing evaluation of outcomes. A central lesson from previous drug policy reform in New Zealand is the need for investment of time and resources in implementation planning, regulatory agency capacity, and ongoing engagement with health stakeholders and the public.

Summary

Abstract

Aim

Method

Results

Conclusion

Author Information

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University;-Chris Wilkins, SHORE & Whariki Research Centre, College of Health, Massey University;-Geoff Noller, Department of General Practice and Rural Health, School of Medicine, University of Otago.

Acknowledgements

Correspondence

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University.

Correspondence Email

m.rychert@massey.ac.nz

Competing Interests

Conflict of interests: MR and CW are currently conducting a study of medicinal cannabis use funded by the Health Research Council (19/647) and Massey University Research Fund. GN is conducting a study of medicinal cannabis use funded by Medical Cannabis Awareness New Zealand (MCANZ), a medical cannabis patient advocacy organisation.

  1. Ministry of Health. Medicinal Cannabis Scheme: Consultation document. Wellington 2019. http://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
  2. Newton-Howes G, McBride S. Medicinal cannabis: moving the debate forward. NZMJ 2016; 129(1445):103–9.
  3. Wilkins C. The case for medicinal cannabis: where there is smoke there may well be fire. NZMJ 2016; 129(1445):11–4.
  4. Braithwaite I, Newton-Howes G, Oldfield K, Semprini A. Cannabis-based medicinal products and the role of the doctor: should we be cautious or cautiously optimistic? NZMJ 2019; 132(1500):82–8.
  5. Satherley D, Prendergast E. Medicinal cannabis users call for amnesty ahead of law change (11 July 2019). Newshub; 2019. Available from: http://www.newshub.co.nz/home/politics/2019/07/medicinal-cannabis-users-call-for-amnesty-ahead-of-law-change.html
  6. Horizon Poll. Specialist sign-off for cannabis would strain health sector (2 August 2019). Results from Horizon Poll survey commissioned by Helius Therapeutics. http://www.horizonpoll.co.nz/page/549/specialist-shttp://www.tga.gov.au/access-medicinal-cannabis-products-1
  7. Therapeutic Goods Administration. Access to medicinal cannabis products. (5 August 2019). 2019.
  8. Victoria State Government. Information for Health Professionals 2019. http://www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis/health-professionals
  9. Rychert M, Wilkins C. Did we have the wrong debate about Elixinol™ and medicinal cannabis? NZMJ 2015; 128(1421):69–70.
  10. Hazekamp A. The Trouble with CBD Oil. Medical Cannabis and Cannabinoids. 2018; 1(1):65–72.
  11. MILDECA (Interministerial Mission for Combating Drugs and Addictive Behaviours). Cannabidiol (CBD) le point sur la législation. (11 June 2018). 2019. http://www.drogues.gouv.fr/actualites/cannabidiol-cbd-point-legislation
  12. Hasse J. This EU Country Has Become The First To Allow Free Sale Of CBD. (23 May 2019). Forbes; 2019. http://www.forbes.com/sites/javierhasse/2019/05/23/this-eu-country-has-apparently-become-the-first-to-allow-free-sale-of-cbd/#714ec5cc36c9
  13. Food and Drug Administration. FDA is Committed to Sound, Science-based Policy on CBD. (17 July 2019) http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-committed-sound-science-based-policy-cbd
  14. MOH. Review of the Psychoactive Substances Act 2013. (14 January 2019) http://www.health.govt.nz/publication/review-psychoactive-substances-act-2013 Archived by WebCite at: http://www.webcitation.org/75v07Ru8I
  15. Rychert M, Wilkins C. New Zealand’s review of the Psychoactive Substances Act 2013: a missed learning opportunity ahead of the national cannabis law reform referendum? Addiction. 2019; 114(6):1129–30.
  16. Rychert M, Wilkins C. A critical analysis of the implementation of a legal regulated market for new psychoactive substances (“legal highs”) in New Zealand. IJDP. 2018; 55:88–94.
  17. Auckland Patients Group. A report from an attendee of the Ministry of Health Consultation scheme. (24 July 2019) http://www.facebook.com/AuckPatientGroup/posts/2727004267312623?__tn__=K-R
  18. Radio New Zealand. Medicinal cannabis regulations: Questions raised over specialist sign-off. (11 July 2019). An interview with Richard Medlicott (College of General Practitioners). 2019. http://www.rnz.co.nz/national/programmes/ninetonoon/audio/2018703643/medicinal-cannabis-regulations-questions-raised-over-specialist-sign-off
  19. Setboonsarng C. Thailand set to deliver first batch of medical marijuana. (2 August 2019) http://www.reuters.com/article/us-thailand-cannabis/thailand-set-to-deliver-first-batch-of-medical-marijuana-idUSKCN1UR4LX
  20. Cannabis Licensing Authority. License eligibility criteria. 2016. http://www.cla.org.jm/application/basic-eligibility-criteria
  21. Pledger M, Martin G, Cumming J. New Zealand Health Survey 2012/13: characteristics of medicinal cannabis users. NZMJ. 2016; 129(1433):25–36.
  22. Fergusson DM, Swain-Campbell NR, Horwood LJ. Arrests and convictions for cannabis related offences in a New Zealand birth cohort. Drug Alcohol Depen 2003; 70(1):53–63.
  23. Cannabis Licensing Authority. Alternative Development Project: including the small traditional ganja farmers in the regulated space. 2018. Available from: http://www.cla.org.jm/sites/default/files/documents/The%20Alternative%20development%20Programme_as%20at%20December%202017.pdf
  24. Office of the Minister of Justice. 2020 Cannabis Referendum - legislative process and overarching policy settings for the regulatory model. Cabinet paper. Considered by Cabinet on 6 May 2019. Released 7 May 2019. http://www.beehive.govt.nz/sites/default/files/2019-05/Proactive%20release%20-%20Cabinet%20paper%20-%202020%20Cannabis%20Referendum%20-%207%20May%202019.pdf
  25. Cox C. Medical Cannabis vs. Recreational Cannabis…. Why we need them both. 2018. http://healthlawmatters.squarespace.com/home/2019/3/18/medical-cannabis-vs-recreational-cannabis-why-we-need-them-both
  26. Cairns E, Kelly M. Why support a separate medical access framework for cannabis? CMAJ. 2017; 189(28):E927–E8.

Contact diana@nzma.org.nz
for the PDF of this article

View Article PDF

The Ministry of Health (MOH) recently released a consultation document outlining proposals for the New Zealand Medicinal Cannabis Scheme (NZMCS) and completed a series of public consultations seeking feedback from industry, patients and medical professionals on a number of complex regulatory issues.1 With less than three months left to finalise the new scheme, pressure is mounting to balance the sometimes conflicting expectations of the various stakeholders. Medical professionals overseas and in New Zealand have long expressed concerns about the quality of evidence concerning the medical benefits of cannabis (ie, specifically the limited number of double-blind placebo-controlled trials).2,3 As a consequence, engaging medical professionals in similar regimes overseas has proved a key challenge.4

Broadly, the MOH consultation document proposes a pharmaceutical access model where products will be available via prescription from pharmacies. The discussion document asked whether an additional recommendation from a specialist doctor should also be required. This level of oversight would be higher than for most other medicines, including opioids—an irony that has not escaped some commentators.5 The suggestion that the New Zealand scheme will require specialist sign-off has attracted negative feedback from patients and the industry, and a mixed response from medical professionals concerned there will not be enough specialists and with the additional pressure placed on the resources of the health system.6

In Australia, the requirement for specialist sign-off led to the opening of private ‘cannabis clinics’ with specialist teams on site, adding to the cost of such consultations and related inequities. However, recent modifications of the Australian regime have addressed these issues, with monthly prescribing figures subsequently increasing 10-fold, from 229 in August 2018 to 2,206 in July 2019.7 The modifications include the streamlining of the GP application process using an online portal, thus avoiding the paperwork previously involved, and most states now allowing specialist GPs to prescribe without having to be endorsed by condition specialists (eg, pain specialists).8

Further key issues put forward for discussion include what medical cannabis products will be available and the related manufacture standards. Smoking and edible products have already been ruled out due to the health risks of smoking and variability in metabolism of edibles respectively, but vaping will most likely be permitted. In terms of manufacture, the Ministry has suggested one scenario in which all products will need to comply with Good Manufacturing Practice (GMP) requirements, the gold standard for pharmaceutical products. An alternative approach is to allow some products to be manufactured to a lower Good Production Practice (GPP) standard. The proposed GPP standard is based on the Canadian approach to non-prescription health products containing cannabis. These products do not undergo any pre-market review for safety.1 Given this NZMCS proposal is strongly based in the pharmaceutical paradigm, it is unclear whether GPs would be comfortable prescribing products manufactured to any standard lower than GMP. Many countries have already adopted GMP for medicinal cannabis and some fledgling New Zealand medicinal companies have expressed interest in this international export market.

We are left wondering if the GPP standard has been proposed in anticipation of a more liberal approach to cannabinoids in the future. The New Zealand Medical Cannabis Council, the cannabis industry group, is currently lobbying to reschedule cannabis-derived cannabidiol (CBD) products from ‘prescription’ to ‘pharmacy-only’ medicines. We have previously argued that CBD products could be classified as dietary supplements due to the absence of the psychoactive ingredient THC.9 CBD is marketed in this way in some countries, but legal uncertainties remain.10 For example, French authorities recently released a new interpretation of the law that allows traces of THC (0.2%) to be present in the plant, but not in the finished CBD products, leading to the closure of numerous ‘CBD cafes’.11 Meanwhile, an American CBD producer received a license to sell CBD foods and supplements in Bulgaria, the first European Union country to officially regulate CBD as a food (potentially at odds with EU law requiring prior market authorisation by the European Food Safety Authority).12 The current review of CBD by the US Food and Drug Administration will likely influence the global industry and regulations in other countries,13 including New Zealand.

The speed at which the NZMCS is now being finalised raises concerns that the new framework may have deficiencies and unintended impacts. While the Misuse of Drugs (Medicinal Cannabis) Amendment Bill was introduced into the house in late January 2018 (as part of the Government’s 100 day plan), it took 11 more months to pass into law, and the legislation states the regulations must be finalised by 18 December 2019. This leaves an extremely tight timeframe to resolve some complex issues. As previously seen with the attempt to regulate “legal highs” via the Psychoactive Substances Act, a rushed policy process can have fatal consequences for implementation.14–16

On social media, medicinal cannabis patients have expressed their frustration at the MOH scheduling of July NZMCS consultation sessions for patients in the evening when their symptoms worsen, and this appears to have contributed to low turnouts.17 In contrast, the morning consultation sessions for the industry were very well attended. This raises the question of who will be the central focus of the regime. The composition of the Medicinal Cannabis Advisory Group includes two representatives from the industry: a cannabis growing company and a private consultancy specialising in commercialisation of biomedical and pharmaceutical products. Some commentators have argued that keeping the industry at arm’s length during the development phase would have been preferable.18 The decision to recover the cost of the new regime from industry licensing fees also appears to establish a dangerous dependency on the commercial success of the new sector. Proposed high licensing fees also create barriers for small-scale, artisan producers who are less focused on commercial success.

The nascent domestic New Zealand medicinal cannabis industry may face considerable competition from already well-established firms from the US, Canada and Israel, raising questions about the extent to which the Government is interested in nurturing a domestic industry. In Thailand, which legalised medicinal cannabis earlier in 2019, foreign investment and imports will be prohibited for five years to allow the domestic medical cannabis industry to become established.19 Under the Jamaican medicinal cannabis scheme (established in 2015), licensed companies must have ‘substantial’ Jamaican ownership control.20 A domestic medicinal cannabis sector may provide opportunities for enhanced regulatory control and local economic development and employment.

There are also questions about the equity of the new regime with regard to addressing the previous disproportionately high Māori arrest rate for minor cannabis offences and the need to promote Māori economic development. The New Zealand Health Survey found that 10.2% of Māori compared to 4.4% of Pakeha self-reported using cannabis medicinally.21,22 The recent legalisation of cannabis in Illinois included expungement of previous cannabis convictions (involving around 770,000 cannabis-related records), and support for people from communities that had been disproportionately impacted by cannabis law enforcement to obtain cannabis business licenses. The Jamaican government is currently implementing an Alternative Development Programme to support local farmers to grow cannabis in a regulated medicinal scheme environment.23

Finally, throughout the NZMCS consultation process there has been little mention of how the medicinal scheme will fit with a possible framework for recreational cannabis use if next year’s referendum is positive. With “grow your own” as an option under the recently released Government framework,24 patients may opt to utilise this means of supply as an alternative to a strictly regulated and likely more expensive NZMCS. Alternatively, if the referendum does not endorse legal recreational cannabis access, disaffected patients may continue to access the potentially cheaper cannabis black market. In Canada, following legalisation of recreational use, the Canadian Medical Association has called for abandonment of medical access scheme, stating it is “no longer necessary”.25 The danger with this outcome is those wishing to use cannabis for medicinal reasons may not have access to safer, medical grade cannabis products and may be less likely to seek professional medical advice.26

Experience from overseas shows medicinal cannabis schemes can be too strictly regulated with overly bureaucratic systems leading to higher healthcare costs, barriers to access and overburdening of the health system. Yet if cannabis is to be treated as a medicine, patient safety and treatment efficacy must remain central principles. There are clear reasons to keep the medicinal cannabis industry at arm’s length from regulatory design decisions. Experience from overseas also suggests that schemes often need to be adjusted over the years to achieve their original objectives, and this underlines the need for regulatory design flexibility and, importantly, ongoing evaluation of outcomes. A central lesson from previous drug policy reform in New Zealand is the need for investment of time and resources in implementation planning, regulatory agency capacity, and ongoing engagement with health stakeholders and the public.

Summary

Abstract

Aim

Method

Results

Conclusion

Author Information

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University;-Chris Wilkins, SHORE & Whariki Research Centre, College of Health, Massey University;-Geoff Noller, Department of General Practice and Rural Health, School of Medicine, University of Otago.

Acknowledgements

Correspondence

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University.

Correspondence Email

m.rychert@massey.ac.nz

Competing Interests

Conflict of interests: MR and CW are currently conducting a study of medicinal cannabis use funded by the Health Research Council (19/647) and Massey University Research Fund. GN is conducting a study of medicinal cannabis use funded by Medical Cannabis Awareness New Zealand (MCANZ), a medical cannabis patient advocacy organisation.

  1. Ministry of Health. Medicinal Cannabis Scheme: Consultation document. Wellington 2019. http://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
  2. Newton-Howes G, McBride S. Medicinal cannabis: moving the debate forward. NZMJ 2016; 129(1445):103–9.
  3. Wilkins C. The case for medicinal cannabis: where there is smoke there may well be fire. NZMJ 2016; 129(1445):11–4.
  4. Braithwaite I, Newton-Howes G, Oldfield K, Semprini A. Cannabis-based medicinal products and the role of the doctor: should we be cautious or cautiously optimistic? NZMJ 2019; 132(1500):82–8.
  5. Satherley D, Prendergast E. Medicinal cannabis users call for amnesty ahead of law change (11 July 2019). Newshub; 2019. Available from: http://www.newshub.co.nz/home/politics/2019/07/medicinal-cannabis-users-call-for-amnesty-ahead-of-law-change.html
  6. Horizon Poll. Specialist sign-off for cannabis would strain health sector (2 August 2019). Results from Horizon Poll survey commissioned by Helius Therapeutics. http://www.horizonpoll.co.nz/page/549/specialist-shttp://www.tga.gov.au/access-medicinal-cannabis-products-1
  7. Therapeutic Goods Administration. Access to medicinal cannabis products. (5 August 2019). 2019.
  8. Victoria State Government. Information for Health Professionals 2019. http://www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis/health-professionals
  9. Rychert M, Wilkins C. Did we have the wrong debate about Elixinol™ and medicinal cannabis? NZMJ 2015; 128(1421):69–70.
  10. Hazekamp A. The Trouble with CBD Oil. Medical Cannabis and Cannabinoids. 2018; 1(1):65–72.
  11. MILDECA (Interministerial Mission for Combating Drugs and Addictive Behaviours). Cannabidiol (CBD) le point sur la législation. (11 June 2018). 2019. http://www.drogues.gouv.fr/actualites/cannabidiol-cbd-point-legislation
  12. Hasse J. This EU Country Has Become The First To Allow Free Sale Of CBD. (23 May 2019). Forbes; 2019. http://www.forbes.com/sites/javierhasse/2019/05/23/this-eu-country-has-apparently-become-the-first-to-allow-free-sale-of-cbd/#714ec5cc36c9
  13. Food and Drug Administration. FDA is Committed to Sound, Science-based Policy on CBD. (17 July 2019) http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-committed-sound-science-based-policy-cbd
  14. MOH. Review of the Psychoactive Substances Act 2013. (14 January 2019) http://www.health.govt.nz/publication/review-psychoactive-substances-act-2013 Archived by WebCite at: http://www.webcitation.org/75v07Ru8I
  15. Rychert M, Wilkins C. New Zealand’s review of the Psychoactive Substances Act 2013: a missed learning opportunity ahead of the national cannabis law reform referendum? Addiction. 2019; 114(6):1129–30.
  16. Rychert M, Wilkins C. A critical analysis of the implementation of a legal regulated market for new psychoactive substances (“legal highs”) in New Zealand. IJDP. 2018; 55:88–94.
  17. Auckland Patients Group. A report from an attendee of the Ministry of Health Consultation scheme. (24 July 2019) http://www.facebook.com/AuckPatientGroup/posts/2727004267312623?__tn__=K-R
  18. Radio New Zealand. Medicinal cannabis regulations: Questions raised over specialist sign-off. (11 July 2019). An interview with Richard Medlicott (College of General Practitioners). 2019. http://www.rnz.co.nz/national/programmes/ninetonoon/audio/2018703643/medicinal-cannabis-regulations-questions-raised-over-specialist-sign-off
  19. Setboonsarng C. Thailand set to deliver first batch of medical marijuana. (2 August 2019) http://www.reuters.com/article/us-thailand-cannabis/thailand-set-to-deliver-first-batch-of-medical-marijuana-idUSKCN1UR4LX
  20. Cannabis Licensing Authority. License eligibility criteria. 2016. http://www.cla.org.jm/application/basic-eligibility-criteria
  21. Pledger M, Martin G, Cumming J. New Zealand Health Survey 2012/13: characteristics of medicinal cannabis users. NZMJ. 2016; 129(1433):25–36.
  22. Fergusson DM, Swain-Campbell NR, Horwood LJ. Arrests and convictions for cannabis related offences in a New Zealand birth cohort. Drug Alcohol Depen 2003; 70(1):53–63.
  23. Cannabis Licensing Authority. Alternative Development Project: including the small traditional ganja farmers in the regulated space. 2018. Available from: http://www.cla.org.jm/sites/default/files/documents/The%20Alternative%20development%20Programme_as%20at%20December%202017.pdf
  24. Office of the Minister of Justice. 2020 Cannabis Referendum - legislative process and overarching policy settings for the regulatory model. Cabinet paper. Considered by Cabinet on 6 May 2019. Released 7 May 2019. http://www.beehive.govt.nz/sites/default/files/2019-05/Proactive%20release%20-%20Cabinet%20paper%20-%202020%20Cannabis%20Referendum%20-%207%20May%202019.pdf
  25. Cox C. Medical Cannabis vs. Recreational Cannabis…. Why we need them both. 2018. http://healthlawmatters.squarespace.com/home/2019/3/18/medical-cannabis-vs-recreational-cannabis-why-we-need-them-both
  26. Cairns E, Kelly M. Why support a separate medical access framework for cannabis? CMAJ. 2017; 189(28):E927–E8.

Contact diana@nzma.org.nz
for the PDF of this article

View Article PDF

The Ministry of Health (MOH) recently released a consultation document outlining proposals for the New Zealand Medicinal Cannabis Scheme (NZMCS) and completed a series of public consultations seeking feedback from industry, patients and medical professionals on a number of complex regulatory issues.1 With less than three months left to finalise the new scheme, pressure is mounting to balance the sometimes conflicting expectations of the various stakeholders. Medical professionals overseas and in New Zealand have long expressed concerns about the quality of evidence concerning the medical benefits of cannabis (ie, specifically the limited number of double-blind placebo-controlled trials).2,3 As a consequence, engaging medical professionals in similar regimes overseas has proved a key challenge.4

Broadly, the MOH consultation document proposes a pharmaceutical access model where products will be available via prescription from pharmacies. The discussion document asked whether an additional recommendation from a specialist doctor should also be required. This level of oversight would be higher than for most other medicines, including opioids—an irony that has not escaped some commentators.5 The suggestion that the New Zealand scheme will require specialist sign-off has attracted negative feedback from patients and the industry, and a mixed response from medical professionals concerned there will not be enough specialists and with the additional pressure placed on the resources of the health system.6

In Australia, the requirement for specialist sign-off led to the opening of private ‘cannabis clinics’ with specialist teams on site, adding to the cost of such consultations and related inequities. However, recent modifications of the Australian regime have addressed these issues, with monthly prescribing figures subsequently increasing 10-fold, from 229 in August 2018 to 2,206 in July 2019.7 The modifications include the streamlining of the GP application process using an online portal, thus avoiding the paperwork previously involved, and most states now allowing specialist GPs to prescribe without having to be endorsed by condition specialists (eg, pain specialists).8

Further key issues put forward for discussion include what medical cannabis products will be available and the related manufacture standards. Smoking and edible products have already been ruled out due to the health risks of smoking and variability in metabolism of edibles respectively, but vaping will most likely be permitted. In terms of manufacture, the Ministry has suggested one scenario in which all products will need to comply with Good Manufacturing Practice (GMP) requirements, the gold standard for pharmaceutical products. An alternative approach is to allow some products to be manufactured to a lower Good Production Practice (GPP) standard. The proposed GPP standard is based on the Canadian approach to non-prescription health products containing cannabis. These products do not undergo any pre-market review for safety.1 Given this NZMCS proposal is strongly based in the pharmaceutical paradigm, it is unclear whether GPs would be comfortable prescribing products manufactured to any standard lower than GMP. Many countries have already adopted GMP for medicinal cannabis and some fledgling New Zealand medicinal companies have expressed interest in this international export market.

We are left wondering if the GPP standard has been proposed in anticipation of a more liberal approach to cannabinoids in the future. The New Zealand Medical Cannabis Council, the cannabis industry group, is currently lobbying to reschedule cannabis-derived cannabidiol (CBD) products from ‘prescription’ to ‘pharmacy-only’ medicines. We have previously argued that CBD products could be classified as dietary supplements due to the absence of the psychoactive ingredient THC.9 CBD is marketed in this way in some countries, but legal uncertainties remain.10 For example, French authorities recently released a new interpretation of the law that allows traces of THC (0.2%) to be present in the plant, but not in the finished CBD products, leading to the closure of numerous ‘CBD cafes’.11 Meanwhile, an American CBD producer received a license to sell CBD foods and supplements in Bulgaria, the first European Union country to officially regulate CBD as a food (potentially at odds with EU law requiring prior market authorisation by the European Food Safety Authority).12 The current review of CBD by the US Food and Drug Administration will likely influence the global industry and regulations in other countries,13 including New Zealand.

The speed at which the NZMCS is now being finalised raises concerns that the new framework may have deficiencies and unintended impacts. While the Misuse of Drugs (Medicinal Cannabis) Amendment Bill was introduced into the house in late January 2018 (as part of the Government’s 100 day plan), it took 11 more months to pass into law, and the legislation states the regulations must be finalised by 18 December 2019. This leaves an extremely tight timeframe to resolve some complex issues. As previously seen with the attempt to regulate “legal highs” via the Psychoactive Substances Act, a rushed policy process can have fatal consequences for implementation.14–16

On social media, medicinal cannabis patients have expressed their frustration at the MOH scheduling of July NZMCS consultation sessions for patients in the evening when their symptoms worsen, and this appears to have contributed to low turnouts.17 In contrast, the morning consultation sessions for the industry were very well attended. This raises the question of who will be the central focus of the regime. The composition of the Medicinal Cannabis Advisory Group includes two representatives from the industry: a cannabis growing company and a private consultancy specialising in commercialisation of biomedical and pharmaceutical products. Some commentators have argued that keeping the industry at arm’s length during the development phase would have been preferable.18 The decision to recover the cost of the new regime from industry licensing fees also appears to establish a dangerous dependency on the commercial success of the new sector. Proposed high licensing fees also create barriers for small-scale, artisan producers who are less focused on commercial success.

The nascent domestic New Zealand medicinal cannabis industry may face considerable competition from already well-established firms from the US, Canada and Israel, raising questions about the extent to which the Government is interested in nurturing a domestic industry. In Thailand, which legalised medicinal cannabis earlier in 2019, foreign investment and imports will be prohibited for five years to allow the domestic medical cannabis industry to become established.19 Under the Jamaican medicinal cannabis scheme (established in 2015), licensed companies must have ‘substantial’ Jamaican ownership control.20 A domestic medicinal cannabis sector may provide opportunities for enhanced regulatory control and local economic development and employment.

There are also questions about the equity of the new regime with regard to addressing the previous disproportionately high Māori arrest rate for minor cannabis offences and the need to promote Māori economic development. The New Zealand Health Survey found that 10.2% of Māori compared to 4.4% of Pakeha self-reported using cannabis medicinally.21,22 The recent legalisation of cannabis in Illinois included expungement of previous cannabis convictions (involving around 770,000 cannabis-related records), and support for people from communities that had been disproportionately impacted by cannabis law enforcement to obtain cannabis business licenses. The Jamaican government is currently implementing an Alternative Development Programme to support local farmers to grow cannabis in a regulated medicinal scheme environment.23

Finally, throughout the NZMCS consultation process there has been little mention of how the medicinal scheme will fit with a possible framework for recreational cannabis use if next year’s referendum is positive. With “grow your own” as an option under the recently released Government framework,24 patients may opt to utilise this means of supply as an alternative to a strictly regulated and likely more expensive NZMCS. Alternatively, if the referendum does not endorse legal recreational cannabis access, disaffected patients may continue to access the potentially cheaper cannabis black market. In Canada, following legalisation of recreational use, the Canadian Medical Association has called for abandonment of medical access scheme, stating it is “no longer necessary”.25 The danger with this outcome is those wishing to use cannabis for medicinal reasons may not have access to safer, medical grade cannabis products and may be less likely to seek professional medical advice.26

Experience from overseas shows medicinal cannabis schemes can be too strictly regulated with overly bureaucratic systems leading to higher healthcare costs, barriers to access and overburdening of the health system. Yet if cannabis is to be treated as a medicine, patient safety and treatment efficacy must remain central principles. There are clear reasons to keep the medicinal cannabis industry at arm’s length from regulatory design decisions. Experience from overseas also suggests that schemes often need to be adjusted over the years to achieve their original objectives, and this underlines the need for regulatory design flexibility and, importantly, ongoing evaluation of outcomes. A central lesson from previous drug policy reform in New Zealand is the need for investment of time and resources in implementation planning, regulatory agency capacity, and ongoing engagement with health stakeholders and the public.

Summary

Abstract

Aim

Method

Results

Conclusion

Author Information

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University;-Chris Wilkins, SHORE & Whariki Research Centre, College of Health, Massey University;-Geoff Noller, Department of General Practice and Rural Health, School of Medicine, University of Otago.

Acknowledgements

Correspondence

Marta Rychert, SHORE & Whariki Research Centre, College of Health, Massey University.

Correspondence Email

m.rychert@massey.ac.nz

Competing Interests

Conflict of interests: MR and CW are currently conducting a study of medicinal cannabis use funded by the Health Research Council (19/647) and Massey University Research Fund. GN is conducting a study of medicinal cannabis use funded by Medical Cannabis Awareness New Zealand (MCANZ), a medical cannabis patient advocacy organisation.

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